JP2608869B2 - Artificial heart valve - Google Patents

Abstract

© Suture rings (13) are provided for heart valves having surrounding stiffening protrusions (25) that are either integral parts of the heart valve bodies (19) or are rigid rings held in interference fit within peripheral grooves (23) of heart valve bodies (19). Metal retainer rings (33) engage the stiffening protrusions (25) to lock the retainer rings (33) to the valve bodies (19) and carry fabric coverings (31) on their exterior surfaces that are suturable to the heart tissues. Deformable portions (41, 45) of the retainer rings (33) are used to provide engagement between the retainer rings (33) and the protrusions (25) and also to permanently position bands (37a, 37b) that secure the fabric coverings (31) to the retainer rings (33).

Description

The present invention relates to a prosthetic heart valve, and more particularly to an improved prosthetic heart valve suturing ring for implanting a heart valve.

A prosthetic heart valve for surgical implantation of the human heart is a check valve that allows blood to flow downstream through the valve and prevents blood from flowing back, ie, backflowing upstream. Despite the relatively simple concept of this check valve, much effort has been put into improving the design of prosthetic heart valves that are implanted in the human heart and function reliably throughout life.

A prosthetic heart valve having a rotating valve member is disclosed in U.S. Pat.
Either in the form of a single occluder, such as that described in U.S. Pat. No. 3,305, or in a pair of leaf-like valve members, such as that described in U.S. Pat. Respond quickly to the flow. As a method of inserting a prosthetic heart valve into the heart, a woven material that can be sutured to the tissue of the heart is usually attached. Frequently, the textile member is attached to a separate suture ring attached to the periphery of the heart valve or orifice ring, for example, as described in US Pat. No. 3,763,548. An important design consideration for the heart valve and its suture ring is to minimize the radial thickness and maximize the size of the heart valve blood passage inserted into a natural passage of a given size. It is to be. For example, by forming a new, thinner heart valve body as an integral structure of pyrolytic carbon, the blood passage of the valve can be made even larger, but the thin heart valve body has Sometimes such valve bodies lack the desired stiffness.

In some cases, the obturator and the valve element have a concave portion and a projecting portion that cooperate with each other, and the elastically deformable valve element allows the obturator to be inserted by deformation, and the elastic valve element Deformation of the heart valve is advantageous if it can resiliently engage the obturator. In addition, the engagement between the occluder and the valve body may be performed by deforming the occluder or by another method. In any case, a deformable valve body is undesirable in an assembled heart valve. After being inserted into the heart, the valve receives little deforming force,
When a surgeon inserts a valve into the heart, the surgeon can inadvertently deform the valve body or shift the position of the occluder. Therefore, the heart valve in combination with the suturing ring must be sufficiently resistant to deformation without risk of movement upon insertion into the heart.

There is still a need for an improved suture ring that, when incorporated with a heart valve, is located in a narrow area along the heart passage and is stiff enough that the valve body does not deform during insertion. . The woven material of the suture ring is continuous and must completely cover the exposed metal portion of the suture ring and avoid exposing seams and woven ends.

It is an object of the present invention to provide a heart valve suturing ring which ameliorates the disadvantages of the prior art as described above.

To this end, a suturing ring of a heart valve according to the invention has a textile jacket for suturing to heart tissue and is secured to a protrusion around the valve body of the valve, which secures the heart valve. Have been. The suturing ring also includes an inner surface lying on an outer surface of the protrusion, a first end surface intersecting one end surface of the protrusion, and a second end surface deformable to intersect the opposite end surface of the protrusion. Have. The textile jacket is secured to the retaining ring by a band, which is permanently placed at a suitable location along the retaining ring.

In a preferred embodiment, the projection to which the retaining ring is fixed is the part that extends outwardly of the reinforcing ring that is housed in the peripheral groove of the valve body in an interference fit.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

FIG. 1 shows a prosthetic heart valve 11 having a suturing ring 13 particularly suitable for insertion into the mitral portion of the heart. The suturing ring has a porous outer jacket 15 that can be sutured to the tissue of the heart and that allows the fibrous tissue of the heart to adhere during treatment.

The illustrated artificial heart valve 11 has a valve body 19 having a blood passage.
And opening and closing means for opening and closing the blood passage. This opening / closing means is, in the illustrated embodiment, the aforementioned U.S. Pat.
It consists of two leaf-shaped valve members as described in US Pat. No. 4,254,508. Specifically, a pair of substantially semicircular valve members 17 are disposed in the blood passage of the valve element 19, and an open position where blood flows through the blood passage and a closed position where blood flows are stopped. To be pivoted between. These valve members 17
Appropriate interengaging means (not shown) comprising recesses or protrusions inside the valve body 19 and protrusions or recesses provided around each valve member so as to engage the recesses or protrusions. ), But this interengaging means does not form part of the invention.

Such a valve body 19 is often made of a material that is somewhat elastically deformable so that it can be deformed when the valve member 17 is inserted. When the valve element 19 returns to the annular shape,
The valve member 17 is pivotally disposed within the valve body by the interengaging means as described above. Particularly suitable materials for the formation of valve members and discs have surfaces with a high degree of antithrombotic properties.
ROLITE] is a pyrocarbon sold under the name.
The valve body made of pyrocarbon or graphite-coated pyrocarbon can be sufficiently deformed to dispose the valve member.

The valve element 19 has a shallow annular groove 23 provided on the outer periphery (see FIGS. 4 and 5). According to one aspect of the present invention, the suturing ring 13 fits into the annular groove 23 of the valve body 19, and further reinforces the valve body so that it does not deform during surgical implantation; It includes a retaining ring 33 and a textile member 31 that can be sutured to the tissue of the heart. The inner surface 27 of the reinforcing ring 25 is held in a tightly fitted state in the annular groove 23 of the valve body.
Is extended outward in the radial direction from the outer surface. The holding ring 33 is provided with a groove 34, and the fabric member 31 is sandwiched and held between the groove 34 and the protrusion 28 protruding outside the reinforcing ring 25.

The textile member 31 is initially tubular in shape, but is folded into a closed loop around the retaining ring 33 to connect both ends 35a, 35b to form a jacket 15 completely surrounding the retaining ring, The joint of the overlapping ends 35 of the tubular fabric member is fixed to the unexposed part. The joint extends from a rigid central ring 43 of the retaining ring and is wrapped by a deformable elastic part consisting of an annular toothed band 41 mounted in a curved shape around the joint.

Generally, the suturing ring 13 is attached to the heart valve as follows. The metal reinforcing ring 25 fits shrink-fit into the groove 23 facing the outside of the valve body 19 by first heating and expanding the diameter.
The textile member 31 is folded into a closed loop around the retaining ring 33, and both ends thereof are connected by attaching means, that is, band means. The first band 37a of the band means is at a first end 35a.
And a second band 37b tied with a pair of cords or straps tied around the second end 35b. Partially (as shown in FIG. 3), the band 41, which has been previously turned outward, is further turned toward the central ring 43 to fix the string and the surrounding fabric. The retaining ring 33 covered with the fabric is then reinforced by a deformable retaining means, i.e., an elastic portion comprising an annular elastic fork 45 extending from the central ring 43 in the opposite direction to the band 41. Pressed on.

In order that the invention may be more fully understood, the suture ring assembly will be described in further detail. It is understood that the heart valve and the suturing ring are disposed within the heart valve in the manner of a replaced living heart valve, but for simplicity of explanation, reference is made to FIGS. Describes that several kinds of members are arranged vertically.

The reinforcing ring 25 is generally annular in shape with a rectangular cross section, but has a chamfered upper outer edge 47 to facilitate application of the reinforcing ring 33 as described below. Inner surface of reinforcement ring 27
Generally corresponds to the shallow groove 23 of the valve element 19, the inner diameter of the reinforcing ring is substantially equal to the groove diameter of the groove, and the height of the reinforcing ring is substantially equal to the height of the groove. The thickness of the reinforcing ring
Since the outer surface 29 of this reinforcing ring is larger than the depth of the groove,
19 project radially outward.

One way to fit the stiffening ring 25 into the groove 23 on one end of the valve body 19 is to first heat the stiffening ring to a high temperature and expand it sufficiently to slide over the ring. A thermally expanded reinforcement ring is placed around the groove, cooled to room temperature, and pressed into the groove at this temperature. The metal forming the reinforcing ring, when heated, has a coefficient of thermal expansion sufficient to be applicable to the valve body. The stiffening ring in the final assembly is shielded from contact with blood and tissue by the jacket 15, but the metal used to form the stiffening ring is selected for biocompatibility and antithrombotic properties. You. Co-Cr alloy is an excellent material for forming a reinforcing ring, and can be heated to about 900 ° F and applied to a valve body.

The retaining ring 33 is manufactured as a one-piece, generally tubular piece of metal which is suitably cut open to form a band 41 and a ring 45 extending in opposite directions from the central ring 43.
The retaining ring is completely covered with a woven material within the complete heart valve-reinforcement ring-retaining ring assembly, but the metal is selected for its biocompatibility and antithrombotic properties. The central portion of the metal retaining ring has a thickness that does not deform under the assembly conditions of the suture ring. The thickness of the annular body 45 is reduced,
Although distorted during the assembly process of the suture ring, the "memory" of the resilient metal causes the annulus 45 to return to its original configuration. The band 41 is relatively thin, deforms beyond its elastic limit, and deforms during assembly of the suture ring. An excellent metal for making retaining rings is titanium. Other metals, such as stainless steel, can be used in the manufacture of the retaining ring, or a material having similar deformation characteristics may be used instead of the metal.

The central ring 43 is relatively thick, giving the retaining ring 33 its shape and rigidity. The inner surface 51 of this central annulus has a diameter slightly larger than the outer diameter of the valve body and accommodates a layer of textile member therebetween.

An annular groove 34 facing inward is formed in the lower part of the central ring 43, and a portion 28 protruding outside of the reinforcing ring 25 is formed in this groove.
Is accommodated, and the lower annular rim 44 remains as it is. groove
34 is adapted to accommodate a single layer of tubular textile member 31 sandwiched between a reinforcing ring and a retaining ring along the upper or overhang 57, vertical 59 and lower 65 surfaces of the groove. I have.

The retaining ring 33 is formed with a plurality of forks (teeth) in an annular body 45 extending downward from the central ring 43 by a plurality of slits 55 to facilitate the interconnection of the retaining ring, the valve body and the reinforcing ring assembly. I do. The lower rim 44 has a slit 55
As a result, it is divided into lugs 61 extending inward in the radial direction at the end of the annular body 45. Preferably, the lower surface 63 of the lug 61 is rounded to make it easier to slide on the upper surface 64 and the outer surface of the reinforcing ring 25 during assembly of the retaining ring, valve body and reinforcing ring assembly. Annulus between lug 61 and central ring 43
The thickness of 45 deforms outward during placement of the retaining ring,
Thereafter, it returns to its original position and surrounds and engages the reinforcing ring.

The thin tubular portion 67 of the retaining ring 33 above the central ring 43 is divided by a plurality of slits 68 into annular teeth. When enough bending stress is applied to a thin tooth, it deforms beyond its elastic limit. Prior to mounting the fabric member, the tubular body 41 has been pre-bent with the aid of suitable dies in the outwardly bent configuration shown in FIG. Together with the outwardly extending flange 71 of 43, an outwardly facing annular portion 79 is formed.

The fabric member 31 is formed from a fabric that is selected to be long lasting and compatible with blood and heart tissue. The knit or knitted fabric has porosity for ingrowth of heart tissue, and the preferred material for the woven member is a Dacron knit woven fabric. The length of the tubular woven member is sufficient to completely encircle the contour of the retaining ring while providing a radially extending flap 75 for suturing to heart tissue.

For ease of handling and suturing, the flap 75 is preferably thickened, for example, a resilient polymeric filler consisting of low density or foamed polytetrafluoroethylene sold under the trade name Teflon. This is preferably done by a ring 76. The filler ring has a semi-elliptical cross-section, its inner surface 78 is substantially vertical, and its diameter corresponds to the outer diameter of the final bent strip 41 as shown in FIG. A suture needle passes easily through the Teflon filler ring 76. In addition, the flap is made of a long textile member 31.
Can be used to increase the thickness by folding the ends multiple times, but in dense knit fabrics it is difficult to pass the suture needles in multiple layers.

The tubular textile member 31 is wrapped around the retaining ring 33 and fitted to the reinforcing ring 25 before being attached to the valve body 19. The textile member 31 is shown in a simple tubular form in FIG. 2, but before being applied to the retaining ring, the textile member is pre-wrinkled, for example by means of a steam iron, so that it is intended to be wrapped. It is preferable to match the shape of the ring as much as possible. Various dies have been used to pre-wrinkle the textile member to conform to the contour of the retaining ring. The textile member is wrinkled to follow the contour of the inwardly facing annular portion 79. On the outside of the retaining ring, a part of the woven material extends from the lower surface 60 of the lug to the retaining ring.
It extends to the upper surface of the center of 33.

Inside the outwardly facing annular portion 79 provided by the pre-bent strip 41, the first, i.e.
The lower end 35a is tightly tied by one of the suture cords 37a, with the short length 81 of the first end extending beyond the knot. The outwardly curved band teeth prevent the tightly tied cord (string) from moving upward. next,
When the filler ring 76 is disposed around the teeth 41 of the pre-bent annular band, the teeth 78 that are not completely bent deform the inner surface 78, as shown in FIG. Woven materials
The second or upper end of 31 is brought around the filler ring 76 and pushed under the teeth of the web to form an annular section.
Tightly tie using the second code 37b inside 79. Second
End overlaps the first end to complete the closed form of the fabric jacket. Free end of the second end extending beyond the knot
83 is folded back to the radially outer portion of the two strings so that they are aligned along the free length 81 of the first end, thereby exposing it to loosening or obstructing blood flow. So that the end of the woven fabric does not remain.

To tie the second cord, its end is passed through the fabric member and tied to the outside of the closed ring of fabric member. The cord holds the fabric member in place along the retaining ring and filler ring. Next, the belt-shaped body 41 is
The cord 37 and the fabric end are secured in an annular portion 79 between the teeth of the bent strip and the flange by bending to the final configuration to extend to the flange 71 of the 43.

The loose multi-layer flap 75 of the textile member is finally steam pressed to extend radially outside the upper end of the retaining ring in a flat annular configuration so that after resection of the heart tissue, particularly the native mitral valve, Suture to the tissue inside the remaining passage. At this stage, the suture ring covered with the fabric is
e can be coated with evaporated carbon sold under the name e to create a highly antithrombotic surface on the exposed fabric.

The coated and coated retaining ring can be applied to a heart valve and reinforcement ring assembly. The retaining ring is pushed down on the valve and stiffening ring assembly, as shown in FIG. When the lower curved surface 63 of the lug 61 touches the chamfered upper edge 47 of the reinforcing ring, the annular body 45 elastically deforms outward and when the flat upper surface 65 of the lug reaches the bottom edge of the reinforcing ring. The annulus springs back inward and secures the retaining ring around the reinforcement ring. With the horizontal upper surface 57 of the groove 34 arranged along the horizontal upper surface 67 of the reinforcing ring 25 and the horizontal lower surface 65 of the groove arranged along the horizontal lower surface 66 of the reinforcing ring, the retaining ring becomes a reinforcing ring. Securely fix.

The retaining ring is secured to the valve body using an inwardly facing annular portion of the retaining ring that abuts around the outer surface 28 of the reinforcing ring, with the woven member sandwiched between the retaining ring and the valve body,
This textile member is maintained firmly. If any loosening occurs inside the woven member during application of the retaining ring to the valve / reinforcement ring assembly, the woven member surrounding the retaining ring has completely covered the protrusion surface of the reinforcing ring. .

FIG. 6 shows a heart valve 11 particularly suitable for insertion into the aorta.
Another specific example of 1 and the surrounding suturing ring 113 is shown. Heart valve 11
1 and the suturing ring 113 are placed in use according to the anatomy of the heart, but for simplicity, with respect to FIGS. 6 to 10, the heart valve and the suturing ring It is shown as having a lower end. The illustrated heart valve 111
Opening / closing means disposed in the valve body 117, that is, a single disc occluder 1
15 for pivoting between an open position for flowing blood through the central passage 119 and a closed position for stopping blood flow in the passage. In the illustrated heart valve 111, the valve body 117 is strengthened by forming a protrusion 121 that is completely annular. It is desirable that the complete projecting portion enhances the shape of the obturator 115 so that it can be sufficiently elastically deformed so that the obturator 115 can be inserted into the valve body 117, or that the obturator 115 can be substantially inserted by any mounting device. It can also be manufactured so that the obturator can be installed on the non-deformable valve body. It should be understood that the aortic suturing ring 113 is equally suitable for use with the heart valve shown with respect to FIGS. 1-5 having an interference stiffening ring in the circumferential groove of the heart valve.

Physiological differences between the mitral portion and the aortic portion require some design differences between the suturing ring used in the mitral portion and the suturing ring used in the aortic portion.
The mitral valve extends between the two ventricles, and removing the defective natural mitral portion opens up a large surface along the entrance. Therefore, it is preferred to attach a wide variety of suture flanges as in the embodiment of FIGS. However, in the aortic region, such wide suture flanges are not suitable for aortic valve suture rings, as the suture ring must be sutured to the wall of the passage. Further, the fabric member 123 in the aortic ring completely covers the surface of the retaining ring 125, but the fabric member 123 has a protruding valve body to further reduce the thickness of the valve and suture ring assembly. Preferably, it does not get caught between the part 121 and the retaining ring, and the fabric member
Valve body 117 and retaining ring 125 above and below 121
Fixed between.

The retaining ring 125 is manufactured as an integral, usually tubular piece of metal. The main body includes a narrow central ring 127 having an inner surface 129 formed closely around an outer surface 131 of the ring-shaped protrusion 121, and extends inside the central ring 127 to form the protrusion 121. Annular flange 1 adjacent to the upper surface of
Consists of 35. The thin tubular portion 139 extends a substantial distance upward from the body and deforms inward during assembly. Since this portion does not deform too much, it is not necessary to form a groove so as to deform without buckling, and the specific example shown may be used.

The lower thin tubular portion 141 extends a substantial distance downward from the body, and the tubular portion substantially deforms during application to the valve body so that it extends a plurality of upwards in the lower tubular portion. Grooves 143 (FIG. 7) are formed to create a plurality of individually deformed grooved toroids 145. Tubular part 141
An inwardly extending rib is formed at the lower end of the tongue to provide an inward protrusion 147 to each annular portion. The annulus 145 in the aortic suturing ring is similar to the annulus of the mitral suture ring, each having an inward protrusion, but the annulus of the aortic suturing ring is similar to that of the mitral valve suture ring. Unlike the press fit, the annular body of the aortic suture ring is bent and engaged around the valve body protrusion 121. However, since the protrusion 147 does not extend sufficiently inward, to place it under the protrusion, the protrusion must be bent until it is irreversibly deformed. Narrow horizontal top surface 1 of annular projection 147
49 allows the retaining ring 125 to be securely fastened to the valve body by bending the annular body. The inner surface 129 of the main body does not extend as much as the distance along the protrusion 121 of the valve body, so that the annular body 145 is much longer, so that it can be more easily bent.

The textile member 123 is not intended to completely surround the retaining ring 125 and is not sandwiched between the inner surface of the central annulus and the protrusion, but the length of the textile member is substantially greater than the height of the retaining ring. Lengthen the material along the outside of the retaining ring
It is also preferred to provide a portion to be sutured to the heart tissue by creating an overlay and to wrap the upper and lower ends and press between the retaining ring and the valve body to retain there by dam rings or bands 151,153 . The woven material is
It is preferably disposed around the end of the retaining ring and pre-wrinkled for winding around the upper and lower fabric retaining bands 151,153.

The fabric retaining bands 151, 153 completely cover the portion of the retaining ring that remains exposed after securing the end of the textile member to the retaining ring, or otherwise securing the retaining ring to the valve body, These bands are made of a solid metallic material. The rigid metal band is a sleeper cord for securing the fabric end between two conventional rigid members, the valve body 117 and the retaining ring 125, to facilitate assembly.

The illustrated bands 151, 153 have a rectangular cross section cut from a cylindrical tube, but bands having a round or other shaped cross section can be used. The band is typically about 0.7 mm axially for hard metals such as titanium.
Has a cross-sectional dimension obtained by multiplying by 0.5 mm in the radial direction.

The upper band 151 is inserted between the upper tubular portion 139 of the retaining ring 125 and the valve body 117 on the protrusion 121 so as to be balanced, so that the wound portion of the textile member 123 wrapping the retaining ring is sufficient around the band. Clearance remains.
Since the outer diameter of the upper ring exactly corresponds to the inner diameter of the upper tubular portion 139, the fabric is trapped between the band 151 and the tubular portion, and the upper tubular portion is bent only slightly inward. Therefore, the upper band can be sufficiently retained at the disposition position on the retaining ring. Insertion of the upper band 151 wrapped with woven fabric and bending inward of the upper tubular portion 139 are usually performed as follows.
Finishing before attaching the retaining ring to the valve body, the upper tubular portion plays no role in securing the retaining ring 125 to the valve body.

The lower band 153 is housed between the annular body 145 and the valve body 117 as shown in FIG. 9, and the outer diameter of the lower band 153 is smaller than the inner diameter of the annular body 145 when there is no bending. Is very small. When the retaining ring 125 is fixed to the valve body, the annular body is bent inward by a substantial distance, and the lower end of the woven fabric member is attached to the band 153 and the lower surface 155 of the protrusion 121.
And hold the lower band 153 in a fixed position between the retaining ring and the protrusion to serve the dual function of securing the retaining ring to the valve body.

To assemble the suturing ring 113, the retaining ring 125 is placed on a jig (not shown) and the woven member 123 is extended through the central passage of the retaining ring, and this portion of the woven material is And The upper band 151 is then inserted into the retaining ring along the inside of the upper tubular portion 139 and the inside of the fabric member 123 and is pushed down to hold the fabric member against the inwardly extending flange 135. At this point, the upper tubular portion 139 is bent inward in the radial direction using a die until the upper end covers the upper band, the upper band is fixed at a predetermined position, the woven fabric member is an upper band, and the upper tubular portion 139 is formed. Fasten firmly between flange 135. Once the fabric member is in place, the top 152 of the fabric member 123 on the retaining ring
Is folded over the upper end of the upper tubular portion 139 and extends downward along the outside of the retaining ring until it reaches the lower end. Next, the remaining portion 154 of the textile member 123 is pulled up through the central passage of the retaining ring, and similarly folded back on the top, along the outside of the retaining ring, the inner layer 152 of the textile member.
Layer on. At this stage, the partially manufactured suturing ring (FIG. 8) is ready to be placed on the heart valve 117 with the protrusion 121 around it and the retaining ring 125 is removed from the jig.

The valve body 117 and the partially manufactured retaining ring 125 are then combined (as shown in FIG. 8). Turn the retaining ring 125 upside down and insert it into another jig (not shown). Valve 11
7 is inserted into the retaining ring 125 so that the projection 121 of the body is located on the flange 135 of the suturing ring so that the outer surface 131 of the projection fits snugly along the inner surface 129 of the central ring 127. Folding inward the portion of the textile member 123 extending below the annulus, pushing the lower band 153 down into the annulus between the inverted valve body 117 and the annulus 143,
The surrounding fabric is carried inside, and the fabric ring 159 is stopped between the band and the valve body 117. Finally, the suture ring is secured to the valve body by bending the annular body 145 inward and pressing it against the lower band 153 and the loop 159 of the textile member and against the protrusion. Excess fabric members that extend outward beyond the ends of the valve body and retaining ring are trimmed.
This fabric can also be coated with evaporated carbon.

Some advantages of this heart valve are as follows. The suture rings are fully assembled with the heart valve prior to insertion into the heart, which are sutured and implanted into the heart. The protrusions, whether integral with the valve body or a separate reinforcing ring, are thin without the protrusions and provide rigidity to the somewhat flexible valve body so that the valve member ,
Excludes the risk of detachment from the valve during surgical implantation into the heart. There is no exposed seam or exposed end on the outer textile member mantle that blood oozes or pulls when pulled. Due to the simple assembly of the retaining ring and the convenient device for fixing the retaining ring to the valve body, the assembly time, which is a large part of the current cost of manufacturing heart valves, is substantially reduced. In particular, in the present invention, the retaining ring has a deformable end, and the deformable end can be movably engaged with the textile member to secure the textile member, thereby making the textile member more efficient. Can be fixed well.

Although the invention has been described with reference to preferred embodiments,
It will be apparent to those skilled in the art that modifications can be made without departing from the scope of the invention.

[Brief description of the drawings]

FIG. 1 is a perspective view of a suture ring applied to a bilobal heart valve for insertion into a mitral portion, which shows various features of the present invention, FIG. 2 is an exploded perspective view of the suture ring, and FIG. FIG. 4 is an enlarged sectional view of the suture ring of FIG. 2 in a state almost ready for combination with FIG. 4;
FIG. 5 is an enlarged partial cross-sectional view similar to that of FIG. 5, FIG. 5 is an enlarged cross-sectional view taken along line 5-5 of FIG. 1, and FIG. 6 is a single disk occluder for insertion into the aorta showing various features of the present invention. FIG. 7 is a perspective view of a specific example of a heart valve and another suturing ring, FIG. 7 is an exploded perspective view of the suturing ring and the heart valve of FIG. 6, and FIG. 8 is ready to be combined with the heart valve. FIG. 9 is an enlarged partial cross-sectional view similar to FIG. 8; FIG. 9 is a view showing a valve inserted into the assembled suture ring of FIG. 8; FIG. It is a -10 line expanded sectional view. 11,111: heart valve, 13,113: suture ring, 19: valve body 33,125: retaining ring, 23: groove, 25: reinforcing ring 121: protrusion, 31,123: textile member 151,153: band, 61: lug

 ────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Harry Webb Cromy Greenhurst Drive 434, Pittsburgh, PA 15243, United States of America 434 (56) References US Patent 4,197,593 (US, A) US Patent 3,691,567 (US, A) )

Claims (8)

(57) [Claims] 1. A valve body (19) having a blood passage and having an annular groove (23) on an outer surface, opening and closing means mounted in the valve body to open and close the blood passage, A reinforcing ring (25) fitted into an annular groove (23) of the valve body and having an outer surface projecting from the outer surface of the valve body;
9) and a deformable fabric member (31) arranged outside the reinforcing ring (25), and a retaining ring (33) for holding the fabric member on the valve body (19) and the reinforcing ring (25).
And attachment means for attaching the textile member (31) to the holding ring (33). The holding ring is formed on an elastic portion and an inner surface of the elastic portion, and a protrusion of the reinforcing ring can be fitted therein. A groove (34), wherein the textile member (31) is arranged in a loop-like manner around the retaining ring (33) and both ends of the textile member are joined by the attachment means to surround the retaining ring. To form a jacket,
The retaining ring is arranged so that the protrusion of the reinforcing ring is fitted into the groove (34) with the textile member (31) interposed between the valve body (19) and the reinforcing ring (25). A prosthetic heart valve, wherein the resilient portion is disposed and is capable of holding the textile member such that the textile member is maintained between the reinforcing ring (25) and the retaining ring. 2. The fixing device according to claim 1, wherein said attaching means comprises a first band for fixing one end of said fabric member to said holding ring, and a second band for fixing the other end of said fabric member to said holding ring. 2. The prosthetic heart valve of claim 1. 3. The artificial heart valve according to claim 2, wherein said elastic portion is permanently bent to fix said first band at a fixed position. 4. The heart valve prosthesis of claim 2 wherein said first and second bands comprise rigid rings. 5. An elastic portion of the retaining ring is press-fitted around the projecting portion, and the elastic portion is deformed outward when press-fitted onto the projecting portion, and then returns to the inside to contact the end face of the projecting portion. 4. A prosthetic heart valve according to claim 2 or 3, which engages. 6. The fabric member surrounds the retaining ring, and the fabric member is sandwiched between the retaining ring and the protrusion by the band means for retaining an opposite end of the fabric member. The artificial heart valve according to any one of claims 2, 3, and 5. 7. The invention as defined in claim 2 wherein said retaining ring has a toothed band substantially surrounding said band means.
Item 7. The artificial heart valve according to any one of Items 3, 3, 5 and 6. 8. The valve body has an annular groove around its periphery, and a reinforcing ring is received in the annular groove by interference fit and extends outside the groove to form the protrusion. An artificial heart valve according to any one of claims 2 to 7.